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Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care.

ABSTRACT: INTRODUCTION:Preterm birth may generate significant distress among the parents, who often present with difficulties in appropriating their parental role. Parental stress and low perceived parental self-efficacy may interfere with the infant's socioemotional and cognitive development, particularly through disrupted parent-infant interactions. Perceived parental self-efficacy represents the belief of efficacy in caring for one's own infant and successful incarnation of the parental role, as well as the perception of one's own abilities to complete a specified task. Interventions to support parental role, as well as infant development, are needed, and parental self-efficacy represents a useful indicator to measure the effects of such early interventions. METHODS AND ANALYSIS:This study protocol describes a randomised controlled trial that will test an early intervention in the neonatal intensive care unit (NICU) (JOIN: Joint Observation In Neonatology) carried out by an interdisciplinary staff team. Mothers of preterm neonates born between 28 and 32 6/7 weeks of gestational age are eligible for the study. The intervention consists of a videotaped observation by a clinical child psychologist or child psychiatrist and a study nurse of a period of care delivered to the neonate by the mother and a NICU nurse. The care procedure is followed by an interactive video guidance intended to demonstrate the neonate's abilities and resources to his parents. The primary outcome will be the difference in the perceived maternal self-efficacy between the intervention and control groups assessed by self-report questionnaires. Secondary outcomes will be maternal mental health, the perception of the parent- infant relationship, maternal responsiveness and the neurodevelopment of the infant at 6 months corrected age. ETHICS AND DISSEMINATION:Ethical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 496/12). Results from this study will be disseminated at national and international conferences, and in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT02736136, Pre-results.

SUBMITTER: Schneider J

PROVIDER: S-EPMC6475149 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care.

Schneider Juliane J Borghini Ayala A Morisod Harari Mathilde M Faure Noemie N Tenthorey Chloé C Le Berre Aurélie A Tolsa Jean-François JF Horsch Antje A

BMJ open 20190330 3

<h4>Introduction</h4>Preterm birth may generate significant distress among the parents, who often present with difficulties in appropriating their parental role. Parental stress and low perceived parental self-efficacy may interfere with the infant's socioemotional and cognitive development, particularly through disrupted parent-infant interactions. Perceived parental self-efficacy represents the belief of efficacy in caring for one's own infant and successful incarnation of the parental role, a ...[more]

PMID: 30928952

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Project description:BACKGROUND:Previous systematic reviews have examined preterm infants' long-term neurodevelopment after neonatal intensive care unit (NICU) discharge, although none have explored the effectiveness of interventions on preterm infants' neurodevelopment during NICU hospitalization. The aim of this review is to evaluate whether interventions, i.e., sensory stimulation, parental involvement, and control of environment, improve preterm infants' neurodevelopment during their NICU hospitalization. METHODS:Experimental studies such as randomized controlled/clinical trials (RCTs) and cluster RCT will be included in this systematic review. Selected studies will be published in English or in French, in the past 15 years from 2002 to 2017. The following electronic databases will be searched to locate relevant studies: CINAHL, MEDLINE, PubMed, EMBASE (OVID), Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science. For all steps in selecting studies, agreement will be reached between two experts in neonatology. Data extraction will be performed independently by the two same experts and will then be compared. The Cochrane assessment tool will be used to screen the studies for risk of bias. A meta-analysis will be performed if the included studies are sufficiently homogeneous. Results will be analyzed using a standardized mean difference (with a 95% confidence interval). Statistical heterogeneity will be evaluated using the ? 2 test at the significance level of 0.1 and the I 2 with the classification suggested by PRISMA-P. If possible, subgroup analyses will be carried out considering preterm infants' gestational age, length of NICU hospitalization, and the characteristics of the intervention such as who delivered it, the type, the dose, the frequency, and the duration. Data synthesis will be performed using the RevMan 5.1 software. Publication bias and selection of variables in publication will be examined using the graphical method of funnel plot and with the statistical test of Egger. Quality of the evidence of all outcomes will be assessed using the Grades of Recommendations Assessment, Development and Evaluation (GRADE) Working Group. DISCUSSION:The results of this systematic review will highlight which interventions are effective for promoting preterm infants' neurodevelopment during NICU hospitalization and will contribute to the body of knowledge in neonatal care by providing guidance for NICU clinical practice and research. SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42017047072.

Project description:BackgroundPreterm infants are high risk for delayed neurodevelopment. The main goal is to develop a program of early intervention for very preterm infants that allows families to apply it continuously at home, and quantify the results of early parental stimulation on improvement of cognition and motor skills.MethodsRandomized clinical Trial including inborn preterm infants with gestational age less than 32 weeks or birth weight less than 1500 g at 48 h after birth. Eligible for begin the intervention up to 7 days after birth. Study Protocol approved by the Brazilian national Committee of ethics in Research and by the institutional ethics committee. Intervention group (IG): skin-to skin care by mother (kangaroo care) plus tactile-kinesthetic stimulation by mothers from randomization until hospital discharge when they receive a program of early intervention with 10 parents' orientation and a total of 10 home visits independently of the standard evaluation and care that will be performed. Systematic early intervention program will be according to developmental milestones, anticipating in a month evolutionary step acquisition of motor and / or cognitive expected for corrected age. Active comparator with a Conventional Group (CG): standard care according to the routine care of the NICU and their needs in the follow up program. Neurodevelopment outcome with blinded evaluations in both groups between 12 and 18 months by Bayley Scales of Infant and Toddler Development third edition and Alberta Motor Infant scale will be performed. All evaluations will be conducted in the presence of parents or caregivers in a safe room for the child move around during the evaluation.DiscussionIf we can show that a continuous and global early intervention at home performed by low income families is better than the standard care for very preterm infants, this kind of program may be applied elsewhere in the world. We received grants by Bill and Melinda Gates Foundation, DECIT, Cnpq and Health Ministry. Grand Challenges Brazil: All Children Thriving.Trial registrationThe study was restrospectively registered in ClinicalTrials.gov . in July 15 2016 ( NCT02835612 ).

Project description:BackgroundPatients' evolving critical illness can be predicted and prevented. However, failure to identify the signs of critical illness and subsequent lack of appropriate action for patients developing acute and critical illness remain a problem. Challenges in assessing whether a child is critically ill may be due to children's often uncharacteristic symptoms of serious illness. Children may seem relatively unaffected until shortly before circulatory and respiratory failure and cardiac arrest. The Bedside Paediatric Early Warning Score has been validated in a large multinational study and is used in two regions in Denmark. However, healthcare professionals experience difficulties in relation to measuring blood pressure and to the lack of assessment of children's level of consciousness. In addition, is it noteworthy that in 23,288-hour studies, all seven items of the Bedside Paediatric Early Warning Score were recorded in only 5.1% of patients. This trial aims to compare two Paediatric Early Warning Score (PEWS) models to identify the better model for identifying acutely and critically ill children. The hypothesis is that the Central Denmark Region PEWS model is superior to the Bedside PEWS in terms of reducing unplanned transfers to intensive care or transfers from regional hospitals to the university hospital among already hospitalised children.Methods/designThis is a multicentre, randomised, controlled clinical trial where children are allocated to one of two different PEWS models. The study involves all paediatric departments and one emergency department in the Central Denmark Region. The primary outcome is unplanned transfer to the paediatric intensive care unit or transfer from regional hospitals to the university hospital. Based on preliminary data, 14,000 children should be included to gain a power of 80% (with a 5% significance level) and to detect a clinically significant difference of 30% of unplanned transfers to intensive care or from regional hospitals to the paediatric department at the university department. A safety interim analysis will be performed after inclusion of 7000 patients.DiscussionThis is the first randomised trial to investigate two different PEWS models. This study demonstrates the safety and effectiveness of a new PEWS model and contributes to knowledge of hospitalised children's clinical deterioration.Trial registrationClinicalTrials.gov, NCT02433327 . Registered on 27 April 2015.

Project description:IntroductionThe PLAYshop programme is a novel, brief, theory-based, parent-focused physical literacy intervention in early childhood designed to address the major public health issue of childhood physical inactivity. The primary objective of this study is to examine the efficacy of the virtually delivered PLAYshop programme in increasing preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment.Methods and analysisThis study aims to recruit 130 families with preschool-aged children (3-5 years) from Alberta and British Columbia, Canada who will be randomised to an intervention or control group. The PLAYshop programme is informed by the Capability, Opportunity, Motivation, Behavior (COM-B) model and includes four intervention strategies: (1) educational training via a 60 min virtual synchronous workshop, (2) educational resources via handouts, (3) material resources via a goody bag of basic active play equipment and (4) follow-up support via access to a digital app with an online toolkit and four biweekly booster lessons (1-week, 3-week, 5-week and 7-week follow-up). To assess the primary outcome of physical literacy, five fundamental movement skills (overhand throw, underhand throw, horizontal jump, hop, one leg balance) will be measured virtually at baseline and 2-month follow-up using the Test of Gross Motor Development (TGMD) and the Movement Assessment Battery for Children-Second Edition (MABC-2) tools. Additionally, children's motivation and enjoyment will also be assessed at baseline and 2-month follow-up by: (1) parental-report using items from the Preschool Physical Literacy Assessment (PrePLAy) and (2) self-report using an adapted Five Degrees of Happiness Likert scale for children. The control group will receive the PLAYshop programme after the 2-month follow-up.Ethics and disseminationThe protocol was approved by the University of Alberta (00093764) and University of Victoria (16-444) Research Ethics Boards. Findings will be disseminated through peer-reviewed publications, conference presentations, social and traditional media and a circulated infographic.Trial registration numberNCT05255250.

Project description:IntroductionApproximately 15%-20% of the adult population self-report symptoms of addictive eating. There are currently limited options for management. Motivational interviewing-based interventions, containing personalised coping skills training, have been found to be effective for behaviour change in addictive disorders (eg, alcohol). This project builds upon foundations of an addictive eating feasibility study previously conducted and co-design process involving consumers. The primary aim of this study is to examine the efficacy of a telehealth intervention targeting addictive eating symptoms in Australian adults compared with passive intervention and control groups.Methods and analysisThis three-arm randomised controlled trial will recruit participants 18-85 years, endorsing ≥3 symptoms on the Yale Food Addiction Scale (YFAS) 2.0, with body mass index >18.5 kg/m2. Addictive eating symptoms are assessed at baseline (pre-intervention), 3 months (post-intervention) and 6 months. Other outcomes include dietary intake and quality, depression, anxiety, stress, quality of life, physical activity and sleep hygiene. Using a multicomponent clinician-led approach, the active intervention consists of five telehealth sessions (15-45 min each) delivered by a dietitian over 3 months. The intervention uses personalised feedback, skill-building exercises, reflective activities and goal setting. Participants are provided with a workbook and website access. The passive intervention group receives the intervention via a self-guided approach with access to the workbook and website (no telehealth). The control group receives personalised written dietary feedback at baseline and participants advised to follow their usual dietary pattern for 6 months. The control group will be offered the passive intervention after 6 months. The primary endpoint is YFAS symptom scores at 3 months. A cost-consequence analysis will determine intervention costs alongside mean change outcomes.Ethics and disseminationHuman Research Ethics Committee of University of Newcastle, Australia provided approval (H-2021-0100). Findings will be disseminated via publication in peer-reviewed journals, conference presentations, community presentations and student theses.Trial registration numberAustralia New Zealand Clinical Trials Registry (ACTRN12621001079831).

Project description:The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges.This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group).The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as infant-mediated sensory experiences of the mother. Consequently, we are enlarging the testing of preterm infant neurodevelopment beyond that of previous research to include outcomes related to mother-infant interactions and mother-infant co-regulation. Our primary objective is to determine whether repeated engagement of the mother and her infant in the intervention's calming activities will improve the infant's developmental trajectory with respect to multiple outcomes. Our secondary objective is to assess the effectiveness of FNI in the physiological and psychological co-regulation of the mother and infant. We include aspects of neurodevelopment that have not been comprehensively measured in previous NICU interventions.ClinicalTrials.gov: NCT01439269.

Project description:INTRODUCTION:Traditional behavioural weight loss trials targeting improvements in physical activity and diet are modestly effective. It has been suggested that sleep may have a role in weight loss and maintenance. Improving sleep health in combination with physical activity and dietary behaviours may be one strategy to enhance traditional behavioural weight loss trials. Yet the efficacy of a weight loss intervention concurrently targeting improvements in physical activity, dietary and sleep behaviours remains to be tested. METHODS AND ANALYSIS:The primary aim of this three-arm randomised controlled trial is to examine the efficacy of a multicomponent m-Health behaviour change weight loss intervention relative to a waitlist control group. The secondary aims are to compare the relative efficacy of a physical activity, dietary behaviour and sleep intervention (enhanced intervention), compared with a physical activity and dietary behaviour only intervention (traditional intervention), on the primary outcome of weight loss and secondary outcomes of waist circumference, glycated haemoglobin, physical activity, diet quality and intake, sleep health, eating behaviours, depression, anxiety and stress and quality of life. Assessments will be conducted at baseline, 6 months (primary endpoint) and 12 months (follow-up). The multicomponent m-Health intervention will be delivered using a smartphone/tablet 'app', supplemented with email and SMS and individualised in-person dietary counselling. Participants will receive a Fitbit, body weight scales to facilitate self-monitoring, and use the app to access educational material, set goals, self-monitor and receive feedback about behaviours. Generalised linear models using an analysis of covariance (baseline adjusted) approach will be used to identify between-group differences in primary and secondary outcomes, following an intention-to-treat principle. ETHICS AND DISSEMINATION:The Human Research Ethics Committee of The University of Newcastle Australia provided approval: H-2017-0039. Findings will be disseminated via publication in peer-reviewed journals, conference presentations, community presentations and student theses. TRIAL REGISTRATION NUMBER:ACTRN12617000735358; UTN1111-1219-2050.

Project description:Preterm infants are at risk for neurodevelopmental disorders, including motor, cognitive or behavioural problems, which may potentially be modified by early intervention. The EU CareToy Project Consortium (http://www.caretoy.eu) has developed a new modular system for intensive, individualized, home-based and family-centred early intervention, managed remotely by rehabilitation staff. A randomised controlled trial (RCT) has been designed to evaluate the efficacy of CareToy training in a first sample of low-risk preterm infants.The trial, randomised, multi-center, evaluator-blinded, parallel group controlled, is designed according to CONSORT Statement. Eligible subjects are infants born preterm without major complications, aged 3-9 months of corrected age with specific gross-motor abilities defined by Ages & Stages Questionnaire scores. Recruited infants, whose parents will sign a written informed consent for participation, will be randomized in CareToy training and control groups at baseline (T0). CareToy group will perform four weeks of personalized activities with the CareToy system, customized by the rehabilitation staff. The control group will continue standard care. Infant Motor Profile Scale is the primary outcome measure and a total sample size of 40 infants has been established. Bayley-Cognitive subscale, Alberta Infants Motor Scale and Teller Acuity Cards are secondary outcome measures. All measurements will be performed at T0 and at the end of training/control period (T1). For ethical reasons, after this first phase infants enrolled in the control group will perform the CareToy training, while the training group will continue standard care. At the end of open phase (T2) all infants will be assessed as at T1. Further assessment will be performed at 18 months corrected age (T3) to evaluate the long-term effects on neurodevelopmental outcome. Caregivers and rehabilitation staff will not be blinded whereas all the clinical assessments will be performed, videotaped and scored by blind assessors. The trial is ongoing and it is expected to be completed by April 2015.This paper describes RCT methodology to evaluate CareToy as a new tool for early intervention in preterm infants, first contribution to test this new type of system. It presents background, hypotheses, outcome measures and trial methodology.ClinicalTrials.gov: NCT01990183. EU grant ICT-2011.5.1-287932.

Project description:BACKGROUND:Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder. The overall aim is to investigate different methods of CRT. METHODS:This is a multicentre, randomised, single-blinded, controlled trial based in early intervention services in National Health Service Mental Health Trusts in six English research sites. Three different methods of providing CRT (intensive, group, and independent) will be compared with treatment as usual. We will recruit 720 service users aged between 16 and 45 over 3 years who have a research diagnosis of non-affective psychosis and will be at least 3 months from the onset of the first episode of psychosis. The primary outcome measure will be the degree to which participants have achieved their stated goals using the Goal Attainment Scale. Secondary outcome measures will include improvements in cognitive function, social function, self-esteem, and clinical symptoms. DISCUSSION:It has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience. TRIAL REGISTRATION:ISRCTN, ISRCTN14678860 , Registered on 6 June 2016.

Dataset Information

Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care.

Publications

Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care.

Similar Datasets

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